Multicenter, Randomized, Double-Blind, Sham Surgery-Controlled Study of CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) to Assess the Efficacy and Safety of Bilateral Intraputaminal (IPu) Delivery in Subjects With Idiopathic Parkinson's Disease
The purpose of this double blind study is to determine whether CERE-120 (adeno-associated virus serotype 2 [AAV2]-neurturin [NTN]) is effective and safe in the treatment of patients with idiopathic Parkinson's Disease. CERE-120 is administered via bilateral stereotactic injections targeting the putaminal region of the brain. The design of this study involves approximately 34 patients receiving CERE-120 treatment via stereotactic surgery and approximately 17 patients receiving sham stereotactic surgery (no CERE-120 administered).
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- genetic : CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN])
- procedure : Sham Surgery
Phase: Phase 2
Ages Eligible For Study:
- Diagnosis of bilateral, idiopathic Parkinson's Disease (PD) based on UK Brain Bank criteria with motor complications despite adequate oral antiparkinsonian therapy. - At least 5 years disease duration, relative to the anticipated date of surgery, since diagnosis of PD. - Males or nonpregnant females 35-75 years of age, inclusive. - A UPDRS motor scale score of 30 or greater in the practically defined off condition during the 30-day eligibility evaluation period. - Stable doses of antiparkinsonian medications and parkinsonian features for the 60-day period preceding the surgical procedure. - No conditions that would render the subject unsuitable for surgery, or that would interfere with any of the assessments of efficacy or safety in this trial. - Subject's informed consent prior to the performance of any study-specific procedures.